Tuesday, January 06, 2015 4:59:09 PM
Here’s how SK knows so much. The Ph III protocol provides for Sunrise patients to continue dosing with Bavi for as long as they have not progressed. ClinicalTrial.gov says " Patients who have not experienced disease progression will continue to receive Bavituximab weekly until progression." The control group patients don’t get those extra doses of Bavi. Thus there is an easy way for SK and Shan to determine roughly how many Bavi arm patients are still progression-free. If Avid has been producing and shipping much more Bavi to the 150 clinics than just the amount needed to get half the enrolled patients through the Bavi dosing required by the official protocol, then Mgmt has a pretty good idea of how well the Bavi arm of the trial is doing.
I welcome comments on this hypothesis. The only road block I can see would be if PPHM has to stockpile in advance with the Sunrise CRO a much larger amount of Bavi than is actually needed for the initial protocol dosing of the 300 Bavi patients and never learns how much of that extra inventory has been used. But such a surplus dosing requirement would seem to very unfair for the FDA to impose. It would add a huge extra cost burden on the Company with very limited value in terms of safeguarding secrecy of trial results. After all, SK can’t tell whether an extra 200 units of Sunrise Bavi dosing are being divided as 2 units for each of 100 Bavi patients or 4 units for each of 50 patients. It could be just 20 Bavi patients who have each survived unusually long and received 10 extra dosing units each.
Thus I conclude that the extra units of Bavi dosing that the Company has sent to the Sunrise CRO give SK a very good generalized idea of how well the Bavi arm of the trial is doing. Remember, the protocol requires that: " Patients who have not experienced disease progression will continue to receive Bavituximab weekly until progression."
If SK does indeed have this positive Sunrise indicator in his pocket, it’s no wonder that he is taking his time to strike the perfect BP deal. If he knows from the large amount of extra dosing he has shipped that TTP is way out there, then this would mean that OS is way out there as well. Depending on how much extra Bavi has been shipped, SK and Shan could estimate the maximum no. of death events in the Bavi arm and how likely Accelerated Approval might be at the 2nd look-in in the fall of 2015. If SK has this ace in his pocket, why wouldn’t he play hard to get with BP.
Recent CDMO News
- Avid Bioservices Reports Financial Results for Third Quarter Ended January 31, 2024 • GlobeNewswire Inc. • 04/24/2024 09:25:33 PM
- Avid Bioservices Announces Receipt of Deficiency Notice from Nasdaq Regarding Late Form 10-Q • GlobeNewswire Inc. • 03/20/2024 11:00:10 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 03/07/2024 11:30:11 AM
- Avid Bioservices Announces Pricing of Private Placement of Convertible Notes • GlobeNewswire Inc. • 03/07/2024 04:58:48 AM
- Avid Bioservices Announces Proposed Private Placement of Convertible Notes • GlobeNewswire Inc. • 03/06/2024 09:32:07 PM
- Avid Bioservices Announces Certain Preliminary Financial Results for Third Quarter Ended January 31, 2024 • GlobeNewswire Inc. • 03/06/2024 09:31:28 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 03/06/2024 09:30:18 PM
- Form SC 13G/A - Statement of acquisition of beneficial ownership by individuals: [Amend] • Edgar (US Regulatory) • 01/26/2024 09:57:52 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/13/2024 12:34:35 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/12/2024 12:39:18 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/12/2024 12:38:30 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/12/2024 12:37:38 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/12/2024 12:36:27 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/12/2024 12:35:47 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/11/2024 12:56:02 AM
- Form SC 13G/A - Statement of acquisition of beneficial ownership by individuals: [Amend] • Edgar (US Regulatory) • 01/08/2024 09:32:36 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/04/2024 12:56:18 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/04/2024 12:55:07 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/04/2024 12:53:58 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/04/2024 12:51:57 AM
- Form SC 13G - Statement of acquisition of beneficial ownership by individuals • Edgar (US Regulatory) • 12/19/2023 09:05:52 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 12/19/2023 12:34:08 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 12/19/2023 12:33:03 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 12/19/2023 12:32:11 AM
NanoViricides Reports that the Phase I NV-387 Clinical Trial is Completed Successfully and Data Lock is Expected Soon • NNVC • May 2, 2024 10:07 AM
ILUS Files Form 10-K and Provides Shareholder Update • ILUS • May 2, 2024 8:52 AM
Avant Technologies Names New CEO Following Acquisition of Healthcare Technology and Data Integration Firm • AVAI • May 2, 2024 8:00 AM
Bantec Engaged in a Letter of Intent to Acquire a Small New Jersey Based Manufacturing Company • BANT • May 1, 2024 10:00 AM
Cannabix Technologies to Deliver Breath Logix Alcohol Screening Device to Australia • BLO • Apr 30, 2024 8:53 AM
Hydromer, Inc. Reports Preliminary Unaudited Financial Results for First Quarter 2024 • HYDI • Apr 29, 2024 9:10 AM